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Completed

NCT Number: NCT04679818

Postoperative Consequences of Intraoperative NOL Titration

To demonstrate that intraoperative NOL-guided titration of fentanyl improves initial recovery characteristics.

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Key information

Conditions

Anesthesia; Adverse Effect

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

Previous work has shown that NOL (Nociception Level) accurately quantifies nociception during general anesthesia.6 Presumably, titrating opioids to NOL will therefore provide individual guidance so that patients will be given about the right amount. Patient given the right amount will presumably awaken quickly when anesthesia is done, and have good initial pain control in the PACU (Post-Anesthesia Care Unit). To the extent that NOL titration facilitates optimal opioid dosing, patients are likely to have better PACU experiences - which would be an important outcome that clinicians and regulators are likely to take seriously.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults having major non-cardiac surgery expected to last ≥2 hours
  • American Society of Anesthesiologists physical status 1-3
  • Age 21-85 years old
  • Planned endotracheal intubation

Exclusion criteria

  • Planned neuraxial or regional block
  • Clinician preference for an opioid other than, or in addition to, fentanyl
  • Non-sinus heart
  • Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and nausea
  • Lack of English language fluency
  • Routine user of psychoactive drugs other than opioids
  • Contraindication to sevoflurane, fentanyl, morphine, or ondansetron.
  • Intracranial surgery.
  • BMI > 40

Treatment and study plan

Routine opioid management

Drug

Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.

Other names: Fentanyl

PMD-200 Nol-guided opioid administration

Device

PMD-200 Nociception level (NOL) values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends

Other names: PMD-200 NOL

Primary outcomes

  1. Pain Scores at 10-minute Intervals for the Initial Hour of Recovery

    Time frame: At 10-minute intervals during the first 60 minutes after extubation.

    Pain scores are measured using a Verbal Response Scale (VRS) every 10 minutes in the initial hour of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.

  2. Pain Scores at 10-minute Intervals for the Initial 30 Minutes of Recovery

    Time frame: At 10-minute intervals during the first 30 minutes after extubation.

    Pain scores are measured using a Verbal Response Scale (VRS) at 10-minute intervals for the initial 30 minutes of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.

Secondary outcomes

  1. Number of Measurements With Pain Score Less Than 5 (vs ≥5) for Initial Hour of Recovery

    Time frame: At 10-minute intervals during the first 60 minutes after extubation.

    Binary repeated-measures outcome of pain score will be defined as a pain score less than 5 (vs ≥5). Pain scores will be measured using a Verbal Response Scale (VRS) at 10-minute intervals for the initial hour of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.

  2. Number of Measurements With Pain Score Less Than 5 (vs ≥5) for the Initial 30 Minutes of Recovery

    Time frame: At 10-minute intervals during the first 30 minutes after extubation.

    Binary repeated-measures outcome will be defined as a pain score less than 5 (vs ≥5). Pain scores will be measured using a Verbal Response Scale (VRS) at 10-minute intervals for the 30 minutes of recovery. VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced.

Other outcomes

  1. Number of Analgesic Rescue Boluses

    Time frame: During the first 60 minutes after extubation.

    Number of analgesic rescue boluses in the first 60 minutes after extubation.

  2. Ramsay Scores During the First 60 Minutes

    Time frame: At 10-minute intervals during the first 60 minutes after extubation.

    Ramsay scores will be measured using Ramsay Sedation Scale every 10 minutes in the initial hour of recovery. Ramsay Sedation Scale: 1 = Patient is anxious and agitated or restless, or both; 2 = Patient is co-operative, oriented, and tranquil; 3 = Patient responds to commands only; 4 = Patient exhibits brisk response to light glabellar tap or loud auditory stimulus; 5 = Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus; 6 = Patient exhibits no response. Frequencies for each score were reported.

  3. Treatment Effect on the Time to Emergence From Anesthesia.

    Time frame: From discontinuation of sevoflurane anesthesia to extubation intraoperatively, assessed up to the timepoint of leaving operation room.

    Time to emergence from anesthesia is defined as minutes from discontinuation of sevoflurane anesthesia to extubation

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Dec 22, 2020
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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